MAUDE Adverse Event Report: EXACTECH, INC. LP TALAR IMPACTOR INSERT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	351-07-04
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, while impacting the talar component, the arms on the plastic part of the talar impactor snapped off and the protector fell off.The surgeon removed all parts/pieces from the patient.There was a surgical delay of <5 minutes; no adverse events as a result.This event is not associated with a revision of exactech products.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H3: per the capa investigation, the broken talar impactor cover reported was likely the result of previously unforeseen misuse which led to fracture of the device.Correction: h6 problem code.

• Brand Name: LP TALAR IMPACTOR INSERT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19341699
• Report Number: 1038671-2024-01312
• Device Sequence Number: 15239507
• Product Code: LXH
• UDI-Device Identifier: 10885862563415
• UDI-Public: 10885862563415
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 351-07-04
• Device Lot Number: 406342007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female